The Effect of Concentrated Pomegranate Juice Consumption on Lipid Profile and Inflammatory Factors in Patients With Type 2 Diabetes
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The aim of this study is to examine the effects of concentrated pomegranate juice on serum lipid profile and some inflammatory factors in patients with type 2 diabetes. Forty patients aged between 25-60 years old from both sexes are recruited. Patients consume 50gr/day concentrated pomegranate juice for 4 weeks. Anthropometric and blood pressure measurements, 3-days food-record questionnaire ,physical activity and fasting blood samples were collected at the beginning and at the end of the study. Fasting blood sugar, lipid profile, TNF- a, IL-6,hs -CRP and adiponectin levels are measured. LDL are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 14, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedDecember 31, 2013
December 1, 2013
11 months
December 14, 2013
December 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Triglyceride change
Baseline and after 4 weeks
Total Cholesterol change
Baseline and after 4 weeks
HDL- Cholesterol change
Baseline and after 4 weeks
LDL- Cholesterol change
Baseline and after 4 weeks
hsCRP change
Baseline and after 4 weeks
TNF- α change
Baseline and after 4 weeks
IL-6 change
Baseline and after 4 weeks
adiponectin change
Baseline and after 4 weeks
Secondary Outcomes (3)
Fasting Blood Sugar change
baseline and after 4 weeks
Blood Pressure change
Baseline and after 4 weeks
Body Mass Index change
baseline and after 4 weeks
Study Arms (1)
50 gr concentrated pomegranate juice
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- male or female 25 to 60 years old
- having type 2 diabetes for at least 6 month
You may not qualify if:
- pregnancy
- lactation
- cardiac disease
- hepatic disease
- respiratory disease
- chronic renal diseases
- acute or chronic inflammation
- retinopathy
- intake of antioxidant supplement
- insulin therapy
- sensitivity to concentrated pomegranate juice
- change oral drug for controlling blood glucose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahvaz Jundishapoor University of Medical Sciences
Ahvāz, Khoozestan, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nutritionist
Study Record Dates
First Submitted
December 14, 2013
First Posted
December 31, 2013
Study Start
January 1, 2013
Primary Completion
December 1, 2013
Last Updated
December 31, 2013
Record last verified: 2013-12